Chronic Pain, Chronic Pain and Comorbid Emotional Problems, Chronic Pain, Psychogenic, Chronic Pain Syndrome, Chronic Pain, Widespread, Fibromyalgia, Fibromyalgia Syndrome, Functional Pain
Conditions
Keywords
Shiatsu, Complementary and Integrative Medicine, Pediatric Chronic Pain, Non-inflammatory Pain, Quality of Life, PedsQL, Adolescent Pain, Manual Therapy, Mind-Body Therapy, Pediatric Rheumatology, Integrative Medicine, Functional Pain, Pain Management
Brief summary
The goal of this clinical trial is to learn if adding Shiatsu therapy to standard treatment can improve quality of life in children and adolescents with chronic pain that is not caused by inflammation. The main question it aims to answer is: Does Shiatsu therapy help improve the quality of life in children with long-lasting pain? All participants will continue their regular treatment and will also: * Receive a 30-minute Shiatsu session once a week for six weeks * Complete questionnaires about their quality of life and family impact before, during, and after the treatment period The study includes about 40 participants between the ages of 10 and 18, who are already being followed at the pediatric pain and rheumatology clinics at Tel Aviv Sourasky Medical Center.
Interventions
BEHAVIORALShiatsu Therapy
Participants will receive one 30-minute session of Shiatsu therapy per week for 6 weeks. Therapy will be provided by trained Shiatsu practitioners under a standardized protocol developed for this study.
Sponsors
Tel Aviv Sourasky Medical Center, Tel Aviv, Israel
Dana-Dwek Children's Hospital
Tel Aviv University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a single-arm, prospective study evaluating the effects of adjunctive Shiatsu therapy on quality of life in children and adolescents with non-inflammatory chronic pain. All participants receive the same intervention without a comparison or control group.
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Children and adolescents aged 10-18 years * Diagnosed with non-inflammatory chronic pain syndromes * Actively followed by the Pediatric Rheumatology and/or Pediatric Pain Clinics at Tel Aviv Sourasky Medical Center (at least twice a year) * Informed consent signed by at least one legal guardian (or both guardians in cases of separated parents) * If participant is 16 years or older, they must also sign the informed consent
Exclusion criteria
* Informed consent cannot be obtained from the participant or their legal guardians * Legal guardians unable to provide informed consent * Patients with severe conditions (e.g., bone metastasis) * Patients unable to participate in Shiatsu therapy sessions * Participation in Shiatsu therapy within 6 months prior to study enrollment * Participant or legal guardian refuses participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0) Generic Core Scale Total Score | Baseline (Day 0), Week 3 (after the 3rd Shiatsu session), Week 6 (after the 6th Shiatsu session, end of intervention), and Week 18 (3 months post-intervention) | The PedsQL 4.0 Generic Core Scale is a validated questionnaire that measures health-related quality of life in children and adolescents. Participants will complete the age-appropriate version of the PedsQL. It includes 23 items across four subscales: physical, emotional, social, and school functioning. Responses are reverse-scored and transformed to a 0-100 scale. Higher scores indicate better quality of life. The change in total score from baseline to follow-up time points will be assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pediatric Quality of Life Inventory Family Impact Module (PedsQL FIM) Total Score | Baseline (Day 0), Week 3 (after the 3rd Shiatsu session), Week 6 (after the 6th Shiatsu session, end of intervention), and Week 18 (3 months post-intervention) | The Pediatric Quality of Life Inventory Family Impact Module (PedsQL FIM) is a validated caregiver-reported questionnaire that assesses the impact of a child's health condition on family functioning. It includes 36 items covering physical, emotional, social, and cognitive functioning, communication, worry, daily activities, and family relationships. Responses are reverse-scored and transformed to a 0-100 scale. Higher scores indicate better family functioning and less caregiver burden. The change in total score from baseline to follow-up time points will be assessed. |
| Change in Pain Intensity (Numerical Rating Scale, NRS) | Baseline (Day 0), Week 3 (after the 3rd Shiatsu session), Week 6 (after the 6th Shiatsu session, end of intervention), and Week 18 (3 months post-intervention) | Pain intensity will be self-reported using the Numerical Rating Scale (NRS), a validated 11-point scale ranging from 0 to 10, where 0 means no pain and 10 means worst possible pain. Participants will rate their pain at each time point. The change in score from baseline to follow-up time points will be assessed. |
Countries
Israel
Contacts
Primary ContactEyal Cohen-Sela, MD
Backup ContactMerav Heshin-Bekenstein, MD
Outcome results
None listed